Biomarker Operations Manager

The Biomarker Operations Manager will work within multidisciplinary, cross-functional project teams to support the development of innovative therapeutics through effective biomarker and translational sample operations. This role is responsible for managing the operational execution and logistics required to support biomarker strategies across oncology clinical studies and ensuring biomarker operations are seamlessly integrated into clinical trial activities.
Key Responsibilities

• Support the implementation and execution of clinical biomarker, translational sample, and companion diagnostic strategies across projects.
• Manage sample logistics and operations for clinical and biomarker samples, working closely with Clinical Trial Teams (CTTs), central laboratories, and specialty lab vendors.
• Plan, coordinate, and oversee operational activities associated with the full biomarker sample lifecycle, including collection, processing, analysis, data transfer, data cleaning, and final sample disposition.
• Provide biomarker operational expertise and guidance to cross-functional teams and clinical trial teams.
• Support data cleaning activities by ensuring oversight of biomarker samples, data transfers, reconciliation procedures, and issue resolution.
• Contribute to site and laboratory feasibility assessments related to biomarker sample collection, handling, storage, and processing requirements.
• Review laboratory specifications, manuals, and sample handling materials while supporting training efforts for investigator sites and study monitors.
• Collaborate with internal stakeholders and external partners to ensure operational readiness and successful study execution.
• Support presentations, training sessions, and educational initiatives for study teams, sites, and vendors as needed.

Qualifications
Required Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Minimum of 3+ years of relevant industry experience.
• Strong knowledge of oncology clinical trials and the role of biomarkers and translational medicine in clinical development.
• Solid understanding of clinical research processes, including ICH, GCP, GLP, regulatory requirements, and legal considerations related to biomarker samples.
• Experience supporting oncology clinical studies within pharmaceutical, biotechnology, or CRO environments.
• Hands-on experience managing biomarker and sample logistics operations.
• Experience working with SOPs, guidance documents, and work instructions, including drafting biomarker-related documentation.

Preferred Skills & Competencies

• Strong project coordination and organizational skills with attention to detail.
• Proactive, self-motivated, and results-oriented mindset.
• Demonstrated ability to collaborate effectively across diverse, cross-functional teams and external stakeholders, including scientists, trial managers, data managers, clinicians, and laboratory vendors.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced clinical development environment.

Equal Opportunity Employer / Disabled / Protected Veterans

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For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

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We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Additional Skills

(none specified)


AllSTEM Representative Contact Info

Account Executive:


Broughton


Branch Phone:


View phone number on click.appcast.io


Location:


Ontario, CA